APPLICATION
ANDA070609
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-03
LATEST ACTION
2021-07-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BUPIVACAINE HYDROCHLORIDEPrescription
BUPIVACAINE HYDROCHLORIDE 0.5% · INJECTABLE · INJECTION
Approval history
2021-07-06Labeling · Supplement 27 · standardAP
2020-12-09Labeling · Supplement 23 · standardAP
2020-12-09Labeling · Supplement 26 · standardAP
2015-08-18Labeling · Supplement 21 · standardAP
2010-04-07Labeling · Supplement 18AP
2004-01-21Labeling · Supplement 13AP
1999-11-02Labeling · Supplement 12AP
1999-07-16Labeling · Supplement 11AP
1996-10-03Manufacturing (CMC) · Supplement 8AP
1996-06-26Manufacturing (CMC) · Supplement 4AP
1995-02-23Manufacturing (CMC) · Supplement 5AP
1990-09-25Labeling · Supplement 3AP
1990-06-22Labeling · Supplement 2AP
1990-05-07Labeling · Supplement 1AP
1987-03-03OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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